Participants in the study were randomized to receive liraglutide (1.8
mg or 1.2 mg dose) or placebo for 26 weeks in addition to metformin and
rosiglitazone. Treatment with liraglutide in addition to metformin and
rosiglitazone resulted in a mean reduction of 1.5% from baseline HbA1c.
Fasting blood glucose levels decreased by 2.4 mmol/L within two weeks on
1.8 mg of liraglutide. More than half of the patients who received
liraglutide reached the American Diabetes Association HbA1c target of <7.0%
compared to 28% of those who received placebo. Likewise, more than 35% of
the patients in the liraglutide groups reached HbA1c < or = 6.5% compared
to 14% in the placebo group. In both cases, the difference between the
groups receiving liraglutide and the group treated with metformin and
rosiglitazone alone was statistically significant.

In addition to improved glucose lowering, liraglutide treatment also
led to significant weight loss. Mean body weight decreased significantly
for liraglutide compared to an increase in weight of 0.6 kg in the
metformin and rosiglitazone only group. Weight is a common problem among
individuals with type 2 diabetes and is one of the most challenging aspects
in managing this condition. Paradoxically, many of the common treatment
regimens for type 2 diabetes actually cause weight gain.

Treatment with liraglutide in LEAD(TM) 4 also led to a statistically
significant decrease in blood pressure as seen in three of the other
LEAD(TM) studies: reductions of 6.71 mmHg and 5.65 mmHg with liraglutide
1.2 mg and 1.8 mg, respectively, were observed compared to a decrease of
1.11 mmHg in the comparator group.

Beta cell function, as assessed by multiple parameters (HOMA, C-peptide
and proinsulin to insulin ratio), was also significantly improved in
subjects who received liraglutide versus the comparator group. Beta cell
function is an important measure of disease progression in type 2 diabetes.

LEAD(TM) 4 is the last of the five phase 3a LEAD(TM) (Liraglutide
Effect and Action in Diabetes) studies to be presented.

"The complete LEAD(TM) clinical trials program provides convincing
evidence that liraglutide represents an effective new treatment approach
for type 2 diabetes," said Dr. Bernard Zinman, Professor of Medicine,
University of Toronto and Director of the Diabetes Centre Mount Sinai
Hospital, Toronto, Canada. "In this clinical trial program, liraglutide
offers effective glucose lowering as monotherapy or as an add on to other
oral antidiabetic therapies while also consistently lowering weight and
blood pressure and enhancing beta-cell function."

About the study

The LEAD(TM) 4 study was a 26-week randomized trial that compared the
efficacy and safety of two different doses of liraglutide (1.2 mg and 1.8
mg, QD) to placebo, all added to metformin 2 g (1 g, BID) and rosiglitazone
8 mg (4 mg, BID). The trial included 533 subjects with a mean age of 55.1
years, mean body mass index of 33.5 kg/m2, and mean HbA1c of 8.3. All
subjects were previously treated with one or more OADs and received run-in
rosiglitazone and metformin therapy before being randomized to liraglutide
or placebo.

Liraglutide Liraglutide

1.2 mg + 1.8 mg + Placebo +

metformin + metformin + metformin +

rosiglitazone rosiglitazone rosiglitazone

N=178 N=178 N=177

Final HbA1c, %

Change HbA1c from 7.0 7.1 7.9

baseline % points -1.48* -1.48* -0.5

% HbA1c achieving

<7.0% 58* 54* 28

% HbA1c achieving

< or = 6.5% 36* 37* 14

Mean change in weight

from baseline, kg -1.02* -2.02 0.60

Mean change in

FPG from baseline,

mmol/L -2.2* -2.4* -0.4

Mean change in

PPG from baseline,

mmol/L -2.6 -2.7* -0.8

% reporting minor

hypoglycemic 9 8 5

events/subject/year 0.38 0.64* 0.17

Mean change in

systolic blood

pressure from

baseline, mmHg -6.7* -5.6* -1.1

*p<0.05 versus placebo

FPG, fasting plasma glucose; OAD, oral antidiabetic drug; PPG,

post-prandial glucose

Safety and tolerability of liraglutide

There were no major hypoglycemic episodes reported during the study.
The rate of minor hypoglycemia (<3.1 mmol/L) was low in all groups (0.38,
0.64 and 0.17 events per subject year with liraglutide 1.2 mg, 1.8 mg and
placebo, respectively). The most frequent adverse event was nausea, which
was reported by 29-40% of patients treated with 1.2 mg and 1.8 mg
respectively. However, nausea levels decreased to the same as the placebo
group after the first 16 weeks of the study and it was not a major reason
for discontinuation during the trial.

About liraglutide

Once-daily liraglutide is the first human Glucagon-Like Peptide-1
(GLP-1) analog developed for the treatment of type 2 diabetes. Liraglutide
works by stimulating the release of insulin only when glucose levels become
too high and by inhibiting appetite. On May 23, 2008, Novo Nordisk
submitted a New Drug Application to the Food and Drug Administration in the
US as well as a marketing authorization application to the European
Medicines Agency in Europe, for the approval of liraglutide for the
treatment of people with type 2 diabetes. A New Drug Application was also
submitted for approval in Japan on July 15, 2008.

About LEAD(TM) (Liraglutide Effect and Action in Diabetes)

The LEAD(TM) program includes five randomized, controlled, double-blind
phase 3a studies, involving about 4,000 people with type 2 diabetes in 40
countries.

Novo Nordisk is a healthcare company with an 85-year history of
innovation and achievement in diabetes care. The company has the broadest
diabetes product portfolio in the industry, including the most advanced
products within the area of insulin delivery systems. In addition to
diabetes care, Novo Nordisk has a leading position within areas such as
hemostasis management, growth hormone therapy, and hormone therapy for
women. Novo Nordisk's business is driven by the Triple Bottom Line: a
commitment to economic success, environmental soundness, and social
responsibility to employees and customers. With headquarters in Denmark,
Novo Nordisk employs more than 26,000 employees in 80 countries, and
markets its products in 179 countries. Novo Nordisk's B shares are listed
on the stock exchanges in Copenhagen and London. Its ADRs are listed on the
New York Stock Exchange under the symbol 'NVO'. For global information,
visit novonordisk.com; for United States information, visit
http://www.novonordisk-us.com.

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